Inspired BlogPerspectives from Inspired Health Strategies and occassional industry experts
A legacy of unethical studies complicates calls for greater participation by African Americans Originally published by: Amy Dockser Marcus, Wall Street Journal, July 14, 2018 Late last year, Justina Crawford decided to swab the inside of her mouth for a saliva sample...
Originally published April 9, 2018, Pharmaforum.com To what extent is patient engagement really valued and acted upon by pharma companies, CROs and hospitals – and what are the most effective methods to retain participants in clinical trials? The seemingly endless...
Healthcare professionals are increasingly adopting value-based care models, and turning to strong patient engagement tactics to drive success. However, the language used in patient engagement and value-based care discussions is sometimes nebulous, difficult to understand, or overlapping with other industry keywords.
In alphabetical order, PatientEngagementHIT.com defines the latest patient engagement buzzwords pertaining to the current rise of value-based care initiatives.
FDA’s efforts to enhance the patient perspective and experience in drug development and review: Statement from FDA Commissioner Scott Gottlieb, M.D.
Benefit-risk assessment is at the heart of what we do to ensure that Americans have access to medical products that are safe, effective and meet their needs.
But we’re also deeply aware that serious chronic illnesses aren’t monolithic. Patient perception of the benefits and risks of different treatment options can vary based on the stage of the disease, the age of onset, alternative therapies available to treat the disease (if any) and whether a novel therapy improves a patient’s ability to function normally, slows the rate of disease progression or impacts other aspects of a patient’s quality of life.
According to the FDA: The Life Sciences Industry Relationship with Patients is About to Change – Yea!
The FDA Patient Focused Drug Development meeting held Monday, March 19, 2018 was a game changer for me – and the life sciences industry. The FDA, specifically, the Center for Drug Evaluation and Research (CDER) Office of Strategic Initiatives is responsible for the implementation of the 21st Century Cures Act. This meeting was the second in a series of workshops to implement a four-stage plan to support the Cures Act. At this workshop, the lead, Theresa Mullins, PhD, Associate Director for Strategic Initiatives, made it clear that the goal of the plan is to ensure the patient has input to the full breadth of drug development – from pre-IND through commercial. This is music to my ears! It stunned me that the FDA has evolved to this degree – and it is going to push the industry.
The 21st Century Cures Act introduced a host of new opportunities for the life sciences industry. The Act is changing how drugs are developed and made available to the US. The Act also put in motion many concepts that, up to this point, have only been discussed, not...